A double-blind, randomised, placebo-controlled study on the safety and efficacy of Palmitoylethanolamide (PEA) for the management of mild to moderate osteoarthritis symptoms.

A double-blind, randomised, placebo-controlled study on the safety and efficacy of Palmitoylethanolamide (PEA) for management of mild to moderate osteoarthritis symptoms

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12615000149561

Enrollment

119

Registered

2015-02-17

Start date

2016-04-08

Completion date

2018-02-02

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Palmitoylethanolamide (PEA), also known as N-(2-hydroxyethyl) hexadecanamide or N-(2-hydroxyethyl)-palmitamide is an endogenous saturated fatty acid derivative. This study aims to investigate the effects of PEA on pain and quality of life in subjects with mild to moderate osteoarthritis and is designed with two active group arms and one placebo arm. The two active group dosages of 300mg and 600mg per day of PEA are similar to dosages used in other studies. The primary outcome measure is the WOMAC OA Index questionnaire. The participant group includes otherwise healthy men and women aged between 40 and 65 years.

Interventions

Arm 1 - Palmitoylethanolamide (PEA) oral dose (tablet) of 300mg per day for 8 weeks. Arm 2 - Palmitoylethanolamide (PEA) oral dose (tablet) of 600mg per day for 8 weeks. The participants will be monitored for adherence through telephone and email contact throughout the treatment phase. All unused product is returned at completion of the study.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

40 Years to 75 Years

Healthy volunteers

Inclusion criteria

Inclusion Criteria Medically diagnosed Osteoarthritis VAS Pain greater than 4 Not using daily prescribed Osteoarthritis medication Males and females 40-75 years of age BMI between 18.5 - 35

Exclusion criteria

Exclusion Criteria All other forms of arthritis and other auto-immune issues Significant joint injury within last 6 months Women that are pregnant or breast feeding Uncontrolled diagnosed serious health conditions such as diabetes, high cholesterol, hypertension, osteoporosis or have digestive disease(s). Known hypersensitivity to herbal drugs/nutritional supplement/ foods Have started used a drug/natural therapy for Osteoarthritis within the last 30 days – Including Fish oil/ Omega 3 supplement Receiving/ prescribed coumandin (Warfarin) or other anticoagulation therapy Current or history of chronic alcohol and/or drug abuse History of cerebrovascular accident, stroke, or transient ischemia. Major depressive disorders, bipolar disorder, psychotic disorder, or generalized anxiety disorder requiring therapy. Currently using other investigational product(s). Have experienced unintended weight loss of more than 15% of body weight in last 6 months. Active substance abuse (alcohol or drug dependency).

Outcome results